BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 21773219 · Received April 4, 2025

    Report

    Report Number
    2135147-2025-01719
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 9, 2025
    Report Date
    April 30, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) AND COMPLAINT HISTORY REVIEWS WERE NOT PERFORMED BECAUSE THIS COMPLAINT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: UNEXPECTED BILATERAL THROMBUS FORMATION AFTER SUCCESSFUL TRANSCATHETER PATENT FORAMEN OVALE CLOSURE WITH AMPLATZER SEPTAL OCCLUDER.

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: UNEXPECTED BILATERAL THROMBUS FORMATION AFTER SUCCESSFUL TRANSCATHETER PATENT FORAMEN OVALE CLOSURE WITH AMPLATZER SEPTAL OCCLUDER.

    Description of Event or Problem · 0

    THE ARTICLE, "UNEXPECTED BILATERAL THROMBUS FORMATION AFTER SUCCESSFUL TRANSCATHETER PATENT FORAMEN OVALE CLOSURE WITH AMPLATZER SEPTAL OCCLUDER", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 44-YEAR-OLD MALE PATIENT WITH PRIOR ISCHEMIC STROKE AND PATENT FORAMEN OVALE. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SIZED AMPLATZER OCCLUDER WAS CHOSEN FOR A PATENT FORAMEN OVALE CLOSURE (PFO). THE PFO PROCEDURE WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED WITH DUAL ANTIPLATELET THERAPY WITH ASPIRIN AND CLOPIDOGREL FOR SIX MONTHS. THE PATIENT WAS SUBSEQUENTLY TRANSITIONED TO SINGLE ANTIPLATELET THERAPY FOR THREE MONTHS WHEN THE PATIENT WAS HOSPITALIZED FOR NEUROLOGICAL SYMPTOMS INCLUDING HYPOSTHENIA AND DYSARTHRIA, SUGGESTIVE OF AN ISCHEMIC STROKE. ECHOCARDIOGRAMS NOTED LARGE, HYPERECHOIC, AND MOBILE FORMATIONS ON DEVICE SUGGESTING THROMBUS FORMATION. THROMBOPHILIC SCREENING SHOWED TENTATIVE POSITIVITY FOR LUPUS ANTICOAGULANT (LAC). A DECISION WAS MADE TO SURGICALLY EXPLANT THE DEVICE AND SURGICAL CLOSURE OF THE INTERATRIAL DEFECT. THE PATIENT WAS DISCHARGED IN STABLE CONDITIONS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MICHELE GALASSO, SCHOOL OF MEDICINE AND SURGERY, MILANO-BICOCCA UNIVERSITY, PIAZZA DELL¿ATENEO NUOVO, 1, 20126 MILAN, ITALY, WITH CORRESPONDING EMAIL: [email protected]].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371941 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL UNK AMPLATZER OCCLUDER

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Life Threatening| R| S| H